Glioma
Conditions
Keywords
Glioma, PET, EGFR vIII, Multimodal neuronavigation, Molecular pathology, PET-CT, Neuronavigation
Brief summary
The epidermal growth factor receptor variant Ⅲ(EGFR vⅢ) is commonly detected in high-grade gliomas, which is also an important epitope in EGFR-targeted therapies and correlated to poor prognosis. However, detection of this mutant usually needs resected tumor samples. For biopsy samples, test results may not represent the EGFR vⅢ status of the whole tumor tissues because of the heterogeneity of tumor. It is also not applicable for patients who are not suitable for surgical procedure due to the tumor location or patients' general conditions. Because of the importance of the epidermal growth factor receptor (EGFR) signal pathway in oncogenesis, maintenance, and progression of high grade glioma, there has been an intense effort to develop noninvasive molecular imaging approach for the selection and monitoring of EGFR-targeted therapies. Based on investigators' previous study, investigators plan to perform PET scanning on the participants with high grade gliomas after the injection of the second generation of EGFR tracer ,89Zr-ABT806, which can be specifically binded to EGFR vⅢ . After fusing the PET and MRI images, investigators precisely obtain the tissue from thehot-spot on the PET image through multimodal-neuronavigation-guided tumor biopsy. EGFRvⅢ status will be detected by molecular methods to analyze the correlation with the 89Zr-ABT806 PET image qualitatively and quantitatively. Investigators' final goal is to detect EGFR vⅢ by noninvasive molecular imaging procedure for the clinical outcome prediction and the selection of EGFR-targeted therapies.
Interventions
DIAGNOSTIC_TEST89Zr-ABT806 PET
Patients will be given IV bolus injection of 89Zr-ABT806(1-2mCi). The first 89Zr-ABT806 PET scan will be performed about 72 to 120 hours after injection of tracer. The second 89Zr-ABT806 PET scan will be performed about 120 to 168 hours after injection of tracer. Semi-quantitative analysis was performed using the maximum standardized uptake value (SUVmax) and T/N ratio.
Sponsors
Huashan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinical manifestations and imaging examination (CT, MRI, et al) are in accordance with high grade glioma 2. No PET/CT scanning contraindications 3. No MRI scanning contraindications 4. Patients older than 18 years old 5. ECOG score between 0 to 2 6. Patients with sufficient bone marrow, kidney and liver function reserve. 7. All patients gave written informed consent.
Exclusion criteria
1. Patient who has received immune therapy, radiation therapy, chemotherapy, hormone drugs, biological products or other clinical trials within 14 days. 2. Patient who has received EGFR monoclonal antibody therapy within 4 weeks. 3. Patients who has not fully recovered form the past drug toxicity reaction (CTCAE in grade 2 or above). 4. Patient who has received major surgery within 7 days. 5. Patients with allergies to immunoglobulin. 6. Breastfeeding women. 7. pregnant women 8. Patients with severe clinical condition. 9. Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The sensitivity and specificity of 89Zr-ABT806 PET | 4 years | After fusing the 89Zr-ABT806 PET and MRI images, investigators precisely obtained the tissue from thehot-spot on the PET image through multimodal-neuronavigation-guided tumor biopsy. EGFRvⅢ status will be analyzed by molecular methods. The sensitivity and specificity of 89Zr-ABT806 PET will be measured with statistic methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The overall survival time of participants | 4 years | regular follow-up |
| The progression-free survival time of participants | 4 year | regular follow-up |
| The correlation between EGFRvIII mutation and prognosis of participants | 4 year | — |
Countries
China
Contacts
Primary ContactDongxiao Zhuang, Professor
Outcome results
None listed